| CTRI Number |
CTRI/2017/07/008957 [Registered on: 03/07/2017] Trial Registered Prospectively |
| Last Modified On: |
03/07/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate a new technique of drainage of bile ducts when conventional endoscopy fails |
|
Scientific Title of Study
|
A Prospective evaluation of preoperative biliary drainage using Endoscopic ultrasound guided hepato-gastrectomy in distal malignant biliary obstruction |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vinay Dhir |
| Designation |
Consultant Gastroenterologist |
| Affiliation |
Global Hospital, Mumbai |
| Address |
Room 301/302, Department of Gastroenterology,Baldota Institute of Digestive Sciences, Global Hospital, Ernest Borges Road, Mumbai
Mumbai (Suburban) MAHARASHTRA 400012 India |
| Phone |
9819920266 |
| Fax |
|
| Email |
vinaydhir@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Vinay Dhir |
| Designation |
Consultant Gastroenterologist |
| Affiliation |
Global Hospital, Mumbai |
| Address |
Room 301/302, Department of Gastroenterology,Baldota Institute of Digestive Sciences, Global Hospital, Ernest Borges Road, Mumbai
Mumbai (Suburban) MAHARASHTRA 400012 India |
| Phone |
9819920266 |
| Fax |
|
| Email |
vinaydhir@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Vinay Dhir |
| Designation |
Consultant Gastroenterologist |
| Affiliation |
Global Hospital, Mumbai |
| Address |
Room 301/302, Department of Gastroenterology,Baldota Institute of Digestive Sciences, Global Hospital, Ernest Borges Road, Mumbai
Mumbai (Suburban) MAHARASHTRA 400012 India |
| Phone |
9819920266 |
| Fax |
|
| Email |
vinaydhir@gmail.com |
|
|
Source of Monetary or Material Support
|
| Endoscopy research foundation,3rd floor, Global Hospital, Ernest Borges Road, Mumbai 400012 |
|
|
Primary Sponsor
|
| Name |
Endoscopy Research foundation |
| Address |
Room 301/302, Department of Gastroenterology,Baldota Institute of Digestive Sciences, Global Hospital, Ernest Borges Road, Mumbai |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| VINAY DHIR |
Global Hospital |
Room 301/302, Department of Gastroenterology,Baldota Institute of Digestive Sciences, Global Hospital, Ernest Borges Road, Mumbai Mumbai (Suburban) MAHARASHTRA |
9819920266
vinaydhir@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Global Hospital, Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Distal biliary obstruction with obstructive jaundice, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Partially covered self expandable metal stent |
These are stents designed for endo luminal use which can be deployed under EUS guidance with standard technique of similar well documented EUS guided interventions. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1 Willing and able to comply with the study procedures and provide written informed consent to participate in the study
2 Diagnosis of probable pancreatic cancer, distal common bile duct (CBD) cholangiocarcinoma and ampullary cancers
3 Biliary obstructive symptoms or signs
4 Bilirubin level > 2 mg/dl
5 Patients deemed as resectable by pancreatic protocol CT or MRI
6 Surgery intent within 4 weeks
|
|
| ExclusionCriteria |
| Details |
1 Biliary strictures caused by confirmed benign tumors
2 Biliary strictures caused by malignancies other than pancreatic cancer, distal CBD cholangiocarcinoma and ampullary cancers.
3 Hilar stricture or obstruction due to any cause.
4 Neoadjuvant chemotherapy for current malignancy
5 Palliative indication due to reasons other than surgical candidate status
6 Previous biliary drainage by ERCP/PTC
7 Patients for whom endoscopic techniques are contraindicated
8 Participation in another investigational trial within 180 days
9 Pregnancy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the technical & clinical success and immediate complications of preoperative biliary drainage by EUS-HGS in patients with distal malignant biliary obstruction |
2, 4, 6, 8 weeks follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
After EUS-HGS in postoperative period (after surgery) to study
1 Length of hospital stay after surgery
2 Biliary obstruction symptoms assessment (Jaundice and prurutis)
|
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="16" Sample Size from India="16"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/07/2017 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Preoperative biliary drainage in distal malignant biliary obstruction is considered to decrease jaundice prior to delayed curative surgery. Present rationale is biliary drainage using ERCP and biliary stenting. Some studies favours direct surgery rather than preoperative drainage, but have certain limitations. Biliary stenting can be done either with plastic or covered metal stent. However, covered metal stents have added advantages such as decrease risk of bleeding, pancreatitis, frequent stent block prior to surgery and are retrievable. EUS-guided biliary drainage (EUS-BD) is an established alternative technique to unsuccessful endoscopic retrograde cholangio-pancreaticography (ERCP) in patients with malignant biliary obstruction. Recent study establishes the short term outcome and complications comparable between EUS-BD and ERCP. In addition complication like pancreatitis was frequent in ERCP than EUS-BD. Among different methods of EUS guided biliary drainage, EUS guided hepatogastric stenting (EUS-HGS) showed more technical and clinical success with comparable complication rate. EUS-HGS has certain advantages over conventional biliary drainage. Firstly challenging step of antigrade guidewire passage both in rendezveous & antegrade stenting is avoided. Secondly, it is more physiological in patients with altered anatomy (congenital or altered) as it requires less repeated puncture.
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